Psoriatic ArthritisNCT06580886
Validation of Handheld Ultrasound Devices in Rheumatology
An observational study of Psoriatic Arthritis, run by Ottawa Hospital Research Institute at 3 sites in 2 countries.
Trial summary
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Jan 2023to 28 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who fulfilled the inclusion and exclusion criterion.
Who may be able to join
- Age ≥18
- Meets the classification for psoriatic arthritis (CASPAR) criteria
- Able to provide an informed consent
- Having peripheral disease phenotype of PsA
- At least one tender and swollen join on the day of US
Who cannot join
- Having isolated axial PsA
- Being in MDA with no tender and swollen joints
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Women's College Research Institute
Toronto, Ontario, M5S 1B2
United States1 site
University of Florida College of Medicine
Gainesville, Florida, 32610
About this study
Official title: Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow).
Read the detailed description
This study is a clinical trial testing the concurrent validity of Clarius handheld ultrasound devices against the gold-standard device to detect characteristics (i.e., anatomical structures and vascular flow) of healthy and rheumatic joints in adult Psoriatic Arthritis patients.
The study will be conducted in 3 centers and 10 patients will be included in each center. Study patients will not be randomized to any group.
Both B mode and Doppler images of the participants' predetermined nail, joint, tendon and enthesitis areas will be recorded with both handheld (Clarius Mobile Health Inc, HD3 L15 scanner, HD3 L20 scanner) and the gold standard device (GE LogicE9/E10) at baseline visit.
Two paper CRFs, patient and physician CRFs, will be filled for each patient during the visit and these will be the source document. The CRFs (eCRFs) will be scanned and uploaded to the SharePoint at each center, within 3 days after the visit. In addition, US images of each patient will be uploaded to the SharePoint. The paper CRFs (source documents) will be kept on site. US images and CRFs uploaded from each center will be reviewed by the research assistant at Ottawa Hospital Research Institute (OHRI) center. If there are any missing or erroneous data in the CRF copy, research assistant will contact the site to ensured that the errors and deficiencies are corrected in source document according to Good Documentation Practice. Site should then re-scan the CRF to the SharePoint, ensuring sequential versioning. Any queries will be confirmed with the site within a week of the data entry. Then the analyzed CRFs data will be transferred to Research Electronic Data Capture (REDCap) ( version 12.4.18 - © 2023 Vanderbilt University) by the research assistant at OHRI. Before each analysis (interim and final), all the paper CRFs and REDCap data will be compared for quality assurance.
The scoring of the US images will be done blindly by the principal investigator at OHRI as stated below.
At the central site (OHRI), the research assistant will give a unique identifier number to each image, for a random quality control and for cross referencing whenever needed. The cropped images, as detailed below, will not have the subject ID visible to the PI at the time of reading but will be accessible for the quality control. (read-only access). The research assistant at OHRI is the only site personnel who has the capacity to uncrop the images in the PowerPoint file (password protected files).
Images will not contain any identifiable information such as Date of Birth (DOB) or initials. The US images will be transferred to a PowerPoint file by the research assistant at OHRI in JPEG format. The research assistant will generate an unblinded master list, inaccessible to other site personnel, to link the slide numbers with the patients and scanned anatomical sites and the slide will have no other information on the patient number or ID. For scoring the images by the PI, a random order slide show will be conducted, irrespective of the machine used or the anatomical site or patient assessed, to ensure blindness to data related to the patient identifiers (The PI will not be blinded to the machine that the image was taken with as the JPEG format that is achieved from different machines are identifiable, but due to the random order scoring, images that belong to the same joint by the different machines are not to be scored consecutively). There will be nine separate powerpoint files, for images of joints, tendons, entheses, nail including power Doppler and gray scale findings; and grey scale file for erosions.
If there are missing images for some sites for any of the probes, the images that were obtained for the same site using other probe(s) will also be excluded. The number of missing joint/tendon/entheses and nail images will be reported. Missing data will not be imputed.
After the images are evaluated blindly, statistical analysis will be completed as described below.
The primary endpoint analysis will be the interrater agreement of detecting any synovitis in B mode with the Clarius and gold standard machine. The kappa coefficients will be evaluated using the guideline outlined by Landis and Koch, where the strength of the kappa coefficients are: 0.01-0.20 slight; 0.21-0.40 fair; 0.41-0.60 moderate; 0.61-0.80 substantial; 0.81-1.00 almost perfect.
For secondary outcomes, the interrater agreement for the presence of Doppler signals within the joints, tenosynovitis, erosions, nail, as well as features of enthesitis (hypoechogenicity, thickening, erosions, enthesophytes, calcifications) will also be evaluated using the same method. The agreement of the semiquantitative grading of the intraarticular findings' severity (synovitis in B mode, Doppler signals, erosions, each being on a scale between 0-3) will be done using weighted kappa analysis.
The study will be completed after the imaging of all patients is completed and the analysis of data is done.
- Conditions
- Psoriatic Arthritis
- Being tested
- Ultrasound
- Keywords
- Psoriatic arthritis, Imaging, Ultrasound
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
All patients having ultrasound with Clarius L15/L20 and GE logic E9/E10 in same visit.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Age ≥18, Meets the classification for psoriatic arthritis (CASPAR) criteria, Able to provide an informed consent, Having peripheral disease phenotype of PsA, At least one tender and swollen join on the day of US Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraarticular synovitis scoring
After the imaging of all patients is completed, intraarticular synovitis scoring will be done based on the OMERACT definitions (scales of 0-3) as follows.
Greyscale inflammatory (hypoechoic) synovial hyperplasia:
Grade 0: no hypoechoic synovial hyperplasia Grade 1: minimal hypoechoic synovial hyperplasia (filling the angle between the periarticular bones, without bulging over the line linking tops of the bones) Grade 2: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones but without extension along the bone diaphysis Grade 3: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones and with extension to at least one of the bone diaphysis
Measured: 6 months
Secondary outcomes (4)
Intraarticular Doppler scoring
After the imaging of all patients is completed, the intraarticular Doppler scoring will be done based on the OMERACT definitions (scales of 0-3).
Power Doppler signal:
Grade 0: no flow in the hypoechoic synovial hyperplasia Grade 1: up to three single spots signals or up to two confluent spots or one confluent spot plus up to two single spots Grade 2: vessel signals in less than half of the area of the synovium (≤50%) Grade 3: vessel signals in more than half of the area of the synovium (>50%)
Also, a lateral view of the 2nd metacarpophalangeal and 5th metatarsophalangeal joints will be recorded in the baseline visit for erosion assessment. Erosions will be described as intra-articular discontinuity of the bony surface seen in 2 perpendicular planes and will be evaluated after the imaging of all patients is completed.
Measured: 6 months
Assessment of nail images
B mode and doppler images of the 2nd nail or most involved nail with all probes (Clarius L20, GE Logic E9/S8) will be recorded in the baseline visit. The loss of the trilaminar appearance and the presence of doppler signal in the nail will be evaluated after the imaging of all patients is completed. During imaging of the nail, if any Doppler signal is detected in nail bed, regardless of its severity, the presence of Doppler signal will be considered positive.
Measured: 6 months
Assessment of tendon images
B mode and Doppler images of the tibialis posterior tendon with Clarius L15 and GE Logic E9/S8 will be recorded in the baseline visit. The presence of tendonitis, tenosynovitis and intratendinous Doppler signal in tibialis posterior tendon will be evaluated after the imaging of all patients is completed.
B mode and Doppler images of the 2nd extensor digitorum tendon with Clarius L20 and GE Logic E9/S8 will be recorded in the baseline visit. The presence of paratenonitis and intratendinous Doppler signal in the extensor digitorum tendon will be evaluated after the imaging of all patients is completed.
Measured: 6 months
Assessment of entheses images
Elementary lesions of enthesitis will be defined and scored as per the GRAPPA US working group's definitions, as used in the multicenter DUET study.
All of the elementary lesions will be assessed for their presence or absence. In addition, some of the lesions will also be scored for their severity using a semiquantitative system (grade 0 to 3). The definitions of each grade are outlined below.
- Hypoechogenicity: Grade 0: Absent Grade 1: Present
- Thickening: Grade 0: Absent Grade 1: Present
- Bone Erosion: Grade 0: Absent Grade 1: Present
- Enthesophyte: Grade 0: No enthesophytes Grade 1: Small enthesophyte Grade 2: Medium enthesophyte Grade 3: Large enthesophytes
- Calcification: Grade 0: No calcifications Grade 1: Punctate hyperechoic area Grade 2: Linear calcification without acoustic shadow Grade 3: Egg-shell calcification with posterior acoustic shadow
- Doppler Signal: Grade 0: No Doppler signal Grade 1:A single confluent Doppler signal or
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start16 Jan 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, University Health Network, Toronto, Novartis
- Responsible party
- Principal investigator, Sibel Aydin, Ottawa Hospital Research Institute
- Investigators
- Sibel Z Aydin, Prof, Principal investigator, Ottawa Hospital Research InstituteLihi Eder, Prof, Principal investigator, Women's College HospitalGurjit Kaeley, Prof, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580886
- Sponsor's protocol ID
- 20220612-01H
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology
- ClinicalTrials.gov ID
- NCT06580886
- Acronym / sponsor ID
- 20220612-01H
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic arthritis, Imaging, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Florida, University Health Network, Toronto, Novartis
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow).
Detailed description
This study is a clinical trial testing the concurrent validity of Clarius handheld ultrasound devices against the gold-standard device to detect characteristics (i.e., anatomical structures and vascular flow) of healthy and rheumatic joints in adult Psoriatic Arthritis patients.
The study will be conducted in 3 centers and 10 patients will be included in each center. Study patients will not be randomized to any group.
Both B mode and Doppler images of the participants' predetermined nail, joint, tendon and enthesitis areas will be recorded with both handheld (Clarius Mobile Health Inc, HD3 L15 scanner, HD3 L20 scanner) and the gold standard device (GE LogicE9/E10) at baseline visit.
Two paper CRFs, patient and physician CRFs, will be filled for each patient during the visit and these will be the source document. The CRFs (eCRFs) will be scanned and uploaded to the SharePoint at each center, within 3 days after the visit. In addition, US images of each patient will be uploaded to the SharePoint. The paper CRFs (source documents) will be kept on site. US images and CRFs uploaded from each center will be reviewed by the research assistant at Ottawa Hospital Research Institute (OHRI) center. If there are any missing or erroneous data in the CRF copy, research assistant will contact the site to ensured that the errors and deficiencies are corrected in source document according to Good Documentation Practice. Site should then re-scan the CRF to the SharePoint, ensuring sequential versioning. Any queries will be confirmed with the site within a week of the data entry. Then the analyzed CRFs data will be transferred to Research Electronic Data Capture (REDCap) ( version 12.4.18 - © 2023 Vanderbilt University) by the research assistant at OHRI. Before each analysis (interim and final), all the paper CRFs and REDCap data will be compared for quality assurance.
The scoring of the US images will be done blindly by the principal investigator at OHRI as stated below.
At the central site (OHRI), the research assistant will give a unique identifier number to each image, for a random quality control and for cross referencing whenever needed. The cropped images, as detailed below, will not have the subject ID visible to the PI at the time of reading but will be accessible for the quality control. (read-only access). The research assistant at OHRI is the only site personnel who has the capacity to uncrop the images in the PowerPoint file (password protected files).
Images will not contain any identifiable information such as Date of Birth (DOB) or initials. The US images will be transferred to a PowerPoint file by the research assistant at OHRI in JPEG format. The research assistant will generate an unblinded master list, inaccessible to other site personnel, to link the slide numbers with the patients and scanned anatomical sites and the slide will have no other information on the patient number or ID. For scoring the images by the PI, a random order slide show will be conducted, irrespective of the machine used or the anatomical site or patient assessed, to ensure blindness to data related to the patient identifiers (The PI will not be blinded to the machine that the image was taken with as the JPEG format that is achieved from different machines are identifiable, but due to the random order scoring, images that belong to the same joint by the different machines are not to be scored consecutively). There will be nine separate powerpoint files, for images of joints, tendons, entheses, nail including power Doppler and gray scale findings; and grey scale file for erosions.
If there are missing images for some sites for any of the probes, the images that were obtained for the same site using other probe(s) will also be excluded. The number of missing joint/tendon/entheses and nail images will be reported. Missing data will not be imputed.
After the images are evaluated blindly, statistical analysis will be completed as described below.
The primary endpoint analysis will be the interrater agreement of detecting any synovitis in B mode with the Clarius and gold standard machine. The kappa coefficients will be evaluated using the guideline outlined by Landis and Koch, where the strength of the kappa coefficients are: 0.01-0.20 slight; 0.21-0.40 fair; 0.41-0.60 moderate; 0.61-0.80 substantial; 0.81-1.00 almost perfect.
For secondary outcomes, the interrater agreement for the presence of Doppler signals within the joints, tenosynovitis, erosions, nail, as well as features of enthesitis (hypoechogenicity, thickening, erosions, enthesophytes, calcifications) will also be evaluated using the same method. The agreement of the semiquantitative grading of the intraarticular findings' severity (synovitis in B mode, Doppler signals, erosions, each being on a scale between 0-3) will be done using weighted kappa analysis.
The study will be completed after the imaging of all patients is completed and the analysis of data is done.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | – | Device: UltrasoundAge ≥18, Meets the classification for psoriatic arthritis (CASPAR) criteria, Able to provide an informed consent, Having peripheral disease phenotype of PsA, At least one tender and swollen join on the day of US |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who fulfilled the inclusion and exclusion criterion.
Key inclusion criteria (5 listed)
- Age ≥18
- Meets the classification for psoriatic arthritis (CASPAR) criteria
- Able to provide an informed consent
- Having peripheral disease phenotype of PsA
- At least one tender and swollen join on the day of US
Key exclusion criteria (2 listed)
- Having isolated axial PsA
- Being in MDA with no tender and swollen joints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAll patients having ultrasound with Clarius L15/L20 and GE logic E9/E10 in same visit. | Device | Psoriatic arthritis |
Primary outcome
Intraarticular synovitis scoring
Time frame: 6 months
After the imaging of all patients is completed, intraarticular synovitis scoring will be done based on the OMERACT definitions (scales of 0-3) as follows. Greyscale inflammatory (hypoechoic) synovial hyperplasia: Grade 0: no hypoechoic synovial hyperplasia Grade 1: minimal hypoechoic synovial hyperplasia (filling the angle between the periarticular bones, without bulging over the line linking tops of the bones) Grade 2: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones but without extension along the bone diaphysis Grade 3: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones and with extension to at least one of the bone diaphysis
4 secondary outcomes
Intraarticular Doppler scoring
Time frame: 6 months
Assessment of nail images
Time frame: 6 months
Assessment of tendon images
Time frame: 6 months
Assessment of entheses images
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Z Aydin, Prof principal investigator
Ottawa Hospital Research Institute
Lihi Eder, Prof principal investigator
Women's College Hospital
Gurjit Kaeley, Prof principal investigator
University of Florida
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Ottawa Hospital Research Institute at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraarticular synovitis scoring (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.